Spinout and Completion of Financing of RSH

12 May 2026

RUA LIFE SCIENCES PLC
("RUA", the "Company" or the "Group")

Spinout and Completion of Financing of RUA Structural Heart

RUA Life Sciences plc (AIM: RUA), the medical device group focused on the exploitation of long-term implantable biostable polymers, is pleased to announce the successful spinout and completion of a fundraise by its subsidiary, RUA Structural Heart Limited ("RUA Structural Heart" or "RSH"), led by the Leducq organization ("Leducq").

Transaction Highlights

·    RSH has raised £3 million through issue of convertible note to Leducq.

·    Intercompany debt of £4.8 million capitalised in convertible note to RUA Life Sciences ("RLS").

·    RUA currently retains 100% equity interest, but Board is independent of RLS.

·    RSH will develop a heart valve for underserved market.

·    RLS no longer funding RSH allowing focus on profitability through CDMO business.

RUA Structural Heart will issue £3.0 million of Convertible Unsecured Loan Stock ("CULS") to Leducq (on the terms set out below) to fund it through the next stage of the development of its novel surgical mitral valve programme, targeted at rheumatic heart disease patients in low- and middle-income countries ("LMICs"). The valve will use RSH's proprietary AurTex™ material, a biostable polymer composite engineered to meet the long-term demands of heart valve leaflets.

Specifically, the funding will cover valve design optimisation, durability and fatigue testing, and animal studies, in preparation for the initiation of a first-in-human clinical study.

About Leducq

The Leducq organization is dedicated to improving human health through international efforts to combat cardiovascular disease.  The organization includes The Leducq Charitable Trust and Leducq Foundation, both based in the Bahamas, the Leducq Foundation for Cardiovascular Research based in Houston, and Broadview Ventures, a venture philanthropic program working out of Boston. 

In 2019, The Leducq Charitable Trust and foundations created a new initiative in rheumatic heart disease (RHD), a significant unmet medical need which disproportionately affects children and young adults.  RHD is predominantly found in low- and middle-income countries.  Leducq's RHD program supports research and development in technology to diagnose and treat patients who have, or are at risk for developing, RHD. 

As a part of this initiative, The Leducq Charitable Trust and foundations have established a focused programme to support the development of durable and affordable heart valve solutions suitable for patients with RHD, which would be appropriate for use at scale in settings where RHD is endemic. Leducq is particularly interested in exploring polymer-based valve technologies as an alternative to traditional tissue or mechanical valves.

The investment in RUA Structural Heart reflects the commitment to advance innovative polymer valve platforms capable of addressing the clinical durability and cost constraints associated with RHD in LMICs.

Development Progress

Since engaging with Leducq last year, RUA's R&D team has progressed from the development of the AurTex material platform to the design of a novel surgical valve specifically engineered for the mitral position.

The new valve has been designed around the key mechanical and biostable properties of AurTex and is intended to mimic the structure and function of the native mitral valve. Bench testing of the valve prototype has demonstrated that it meets the hydrodynamic performance targets required for the mitral position, supporting its advancement into durability testing and pre-clinical studies.

Spinout Details

The spinout structure is intended to create a vehicle with the sole focus of developing and commercialising next generation heart valves by incorporating the properties of AurTex. The initial priority will be the development of a novel mitral valve designed to address the large unmet clinical needs of LMICs. It is intended that AurTex will also be introduced into both surgical and trans-catheter valves for the treatment of aortic valve stenosis, the prevalent valve disease in High Income Countries where RHD has mainly been eliminated.

The R&D engineers responsible for AurTex and the novel mitral design will transfer to RSH as direct employees. RLS will continue to provide the necessary infrastructure to allow RSH to concentrate on valve development and testing. The funding from Leducq will finance the valve development programme and the building of the team to take the valve through to the clinic.

The engineers are supported by two globally recognised heart valve experts. John Ely, a RUA Life Sciences director and inventor of the market leading On-X mechanical valve, is joined on the board of RSH by Andy Campbell who for a number of years was Senior VP in charge of Research and Development at the world's largest heart valve company, Edwards Life Sciences.

With the assistance of Broadview, RSH has been structured to be in a strong position to attract next round finance from the more specialist private equity funds in the healthcare sector.

Financing Structure

The financing has been structured through the issue of £3.0 million of Convertible Unsecured Loan Stock ("CULS") by RUA Structural Heart to the Leducq Foundation. The CULS carry a 5 per cent. payment-in-kind ("PIK") coupon and are convertible at a 20 per cent. discount to the valuation established at the next equity funding round of RUA Structural Heart.

In addition, existing RUA Life Sciences' intercompany debt of £4.8 million has been converted into CULS, standing pari passu with the Leducq Foundation CULS including being entitled to a 5 per cent PIK coupon.

On completion of the funding, RUA Life Sciences retains 100 per cent. of the equity share capital of RUA Structural Heart. Following the conversion of the Leducq and RUA Life Sciences CULS and management incentive strip this equity interest will be diluted but is not expected to fall below 62% immediately before the next equity round.

Accounting Treatment and Financial Impact

As a result of the board structure adopted in connection with the financing, RUA Life Sciences will no longer consolidate the results of RUA Structural Heart but will instead account for the holding as an investment.

On de-consolidation, the Group expects to recognise a non-cash accounting gain of approximately £4.9 million.

Eliminating RUA Structural Heart's operating costs and recognising the CULS PIK interest will have a positive annual impact of around £750,000.

RUA Structural Heart Governance

Following completion of the financing, RUA Structural Heart will operate as an independent company with its own expanded board and governance structure.

The initial Board of RUA Structural Heart will comprise:

·      A Chief Executive Officer- role currently held by William Brown.

·      A RLS appointee, currently John Ely, Non-Executive Director of RUA Life Sciences and a heart valve industry veteran

·      Andy Campbell as an investor appointee- formerly Head of Research & Development at Edwards Lifesciences. and

·      David Prim, representing the Leducq organization.

Andy Campbell brings more than four decades of structural heart experience. Andy ran R&D for Medtronic Heart Valves and more recently was responsible for surgical products at Edwards Life Sciences including the development of RESILIA tissue now used in Edwards surgical and transcatheter valves. His experience spans product design, regulatory strategy, manufacturing scale-up and clinical translation of heart valve platforms.

Use of Proceeds

The capital raised will be deployed by RSH to:

·      Complete valve design optimisation.

·      Undertake durability and fatigue testing.

·      Conduct animal studies.

·      Prepare for the initiation of a first-in-human clinical study. and

·      Recruit and build the team to take the company to the next stage.

Comments

William Brown, Chief Executive Officer of RUA Life Sciences, commented:

"We are delighted that RUA Structural Heart has completed this financing with the support of Leducq, their long-standing commitment to tackling rheumatic heart disease and advancing polymer-based valve solutions makes them an ideal partner as RSH moves its novel mitral valve programme towards first-in-human evaluation.

The revised governance structure enables RUA Life Sciences to report RUA Structural Heart as an investment, resulting in a strengthened balance sheet and improved ongoing profitability profile for the Group."

Andy Campbell, Director of RUA Structural Heart, added:

"One of the fundamental challenges with non-reinforced polymer leaflets is the risk of catastrophic failure through leaflet tearing. By incorporating a textile substrate within a fibre-reinforced polymer structure, the RUA team has designed a leaflet intended to eliminate that mode of failure while maintaining the flexibility required for mitral valve function.

Combined with the novel valve architecture and a scalable method of manufacture, this approach has the potential to meet both the demanding clinical performance requirements of the mitral position and the affordability needs of healthcare systems in low- and middle-income countries."

David Milan, Chief Scientific Officer of Leducq Corporation, concluded:

"Leducq is excited and proud to support RUA Structural Heart in its efforts to develop a novel mitral valve using AurTex. If successful, this technology will be life-changing for the millions of people living with advanced RHD worldwide."

Further updates will be provided as the programme progresses.

For further information, please contact: